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N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.
A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops.
Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM.
PMID: 29527973 Full Text at NEJM
Related Editorial in JAMA by Karen L. Margolis
Introduction
Racial disparities in health in the United States have been well documented, and federal initiatives have been undertaken to reduce these disparities. The 1985 Report of the Secretary's Task Force on Black and Minority Health highlighted the need to address disparities in health within the United States. Since then, awareness of health disparities has increased, however, there has been little progress in reducing these racial disparities. The standard approach to reducing health disparities focused primarily on diseases and on healthcare services. Using a population health approach complemented by efforts of public health agencies to address factors impacting the health of different populations offers a more comprehensive and integrated approach.
Source: The Future of the Public's Health in the 21st Century, NAP, 2002, full text link
African Americans are 40% more likely to have high blood pressure are less likely to have their blood pressure under control. Nearly 44% of African American men have some form of cardiovascular disease, and African American men are 60% more likely to die from a stroke than their white male counterparts. According to NHANES 2009–2012 data, the age-adjusted prevalence of hypertension among U.S. adults was 29%. The prevalence was highest among non-Hispanic blacks (42 %). Among adults with hypertension in 2011-2012, 82.8% were aware of their hypertension, 75.7% were currently taking medication to lower their blood pressure, and 51.9% had their blood pressure controlled to less than 140/90 mm Hg.
Figure: Age-specific and age-adjusted prevalence of hypertension among adults aged 18 and over: United States, 2011–2012
Hypertension is a common and manageable chronic condition. However, the control of hypertension has neither met the goal of the Healthy People 2020 (61.2% by 2020) nor the Million Hearts Initiative (65% by 2017). These results provide evidence for continued efforts to improve the management of hypertension in order to attain these goals.
At the end of last year, the new ACC and American Heart Association (AHA) guidelines for the detection, prevention, management and treatment of high blood pressure were released and discussed at nephjc. The recommendations are that high blood pressure be treated earlier with lifestyle changes and in some patients with medication. Unlike previous guidelines, the 2017 guideline emphasizes individualized cardiovascular risk assessment and aggressive management of blood pressure at levels of 140/90 mm Hg or higher in patients with a 10-year risk of cardiovascular events of more than 10%. Patients with blood pressures of 130 to 139/80 to 89 mm Hg would still receive nonpharmacologic treatment, unless they had a 10-year risk above 10%; in that case, a single antihypertensive agent is recommended, along with lifestyle changes.
Blood pressure categories in the new guideline are:
Normal: Less than 120/80 mm Hg;
Elevated: Systolic between 120-129 and diastolic less than 80;
Stage 1: Systolic between 130-139 or diastolic between 80-89;
Stage 2: Systolic at least 140 or diastolic at least 90 mm Hg;
Hypertensive crisis: Systolic over 180 and/or diastolic over 120, with patients needing prompt changes in medication if there are no other indications of problems, or immediate hospitalization if there are signs of organ damage.
The lowered threshold for hypertension increases its prevalence compared with the JNC7 thresholds.
Percentage of US Adults Meeting the Definition for Hypertension and Recommended Antihypertensive Medication According to the 2017 ACC/AHA Guideline and the JNC7 Guideline Based on the 2011–2014 NHANES. From Muntner et al, Circulation, 2018
Victor et al in a previous randomized trial found that it was feasible to enlist barbers in black barbershops to measure blood pressures, correctly stage hypertension, and make a referral to a clinician for treatment. In this study the planned to assess whether health outreach to barbershops will actually improve hypertension management when patrons were given blood pressure medications prescribed pharmacists.
Methods
The study included a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention or to an active control approach.
Those recruited were
Self-identified regular patrons (≥1 haircut every 6 weeks for ≥6 months) who were non-Hispanic black men,
35 to 79 years of age,
Systolic blood pressure of 140 mm Hg or more on two screening days.
Intervention
Barbers in shops assigned to the intervention were trained to encourage pharmacist follow-up and measure blood pressure. The pharmacists prescribed an antihypertensive drug regimen, measured blood pressure, encouraged lifestyle changes, and monitored plasma electrolyte levels. In the absence of insurance limitations the pharmacists prescribed amlodipine combined with an ACEi or ARB as the first line agent with indapamide as the third-line agent.
Outcomes
The primary outcome was the reduction in systolic blood pressure at 6 months.
Secondary outcomes included diastolic pressure, rates of meeting blood-pressure goals, numbers of antihypertensive drugs, adverse drug reactions, self-rated health,3 and patient engagement according to a validated instrument.
Statistical Analysis
With an enrollment target of 10 barbershop clusters per trial group — 25 participants per cluster, a rate of cohort retention of 70%, and an estimated intraclass correlation coefficient of 0.014 — the initial design yielded 90% power to detect a 6.9 mm Hg greater reduction in systolic blood pressure at 6 months in the intervention group than in the control group, with a two-sided alpha level of 0.05. The intervention effect was estimated by means of a linear mixed-effects model, which included a random cluster effect. The primary predictor was an indicator for intervention group versus control group. Given the sample size, the model included three baseline covariates: baseline blood pressure, a doctor for routine medical care (yes vs. no), and high cholesterol level (yes vs. no). These were either strongly correlated with the dependent variable or showed baseline imbalance between the two groups.
Results
Trial Sites and Trial Participants (Figure 1 and Table 1)
The authors enrolled a cohort of 319 participants with systolic blood pressure of 140 mm Hg or higher from 52 black owned barbershops. The primary statistical analysis is based on 132 participants in 28 intervention shops and 171 participants in 24 control shops that completed a 6-month follow-up. Retension was 95% in both groups.
Table 1 from Victor RG et al. N Engl J Med 2018
Figure 1 Victor RG et al. N Engl J Med 2018
Outcomes (Table 2 and Figure 2)
At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group . At 6 months, the mean systolic pressure fell 27.0 mm Hg (to 125.8 mm Hg) in the intervention group versus 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction in systolic blood pressure was 21.6 mm Hg greater in the intervention group than in the control group (95% confidence interval [CI], 14.7 to 28.4; P<0.001).
The size of the intervention effect was similar in the intention-to-treat analysis: the mean reduction was 21.0 mm Hg greater in the intervention group than in the control group (95% CI, 14.0 to 28.0; P<0.001) The intervention effect was consistent across clusters (Fig. 2).
The mean reduction in diastolic blood pressure was 14.9 mm Hg greater in the intervention group than in the control group (95% CI, 10.3 to 19.6; P<0.001), with similar values in the intention-to treat analysis. Blood-pressure goals were met by a higher percentage of participants in the intervention group than in the control group.
Table 2 from Victor RG et al. N Engl J Med 2018
Figure 2 Victor RG et al. N Engl J Med 2018
Changes in Doctor Visits and Medication (Table 3)
The mean (±SD) number of doctor visits that participants reported for the 3 months before baseline was similar in the intervention and control groups (1.0±1.2 and 1.2±1.4, respectively), as was the mean number of visits between 3 months and 6 months after enrollment (1.2±1.5 and 1.1±1.3, respectively).
After 6 months, the use of antihypertensive medication increased from 55% to 100% in the intervention group and from 53% to 63% in the control group (P<0.001). The intervention led to a greater number of antihypertensive drug classes per regimen and higher percentages of participants treated with preferred first-line and add-on drugs than did the active control.
In addition, participants in the intervention group were more likely than those in the control group to be treated with long-acting drugs such as amlodipine, irbesartan or telmisartan (ARBs), and indapamide.
Table 3 Victor RG et al. N Engl J Med 2018
Safety Outcomes
There were no treatment-related serious adverse events in either group. In the intervention group, transient acute kidney injury developed in three participants. In each case, the regimen included indapamide; the acute kidney injury resolved when indapamide was stopped. There was no data on acute kidney injury in the control group.
Patient-Reported Outcomes
Self-rated health and patient engagement increased more in the intervention group than in the control group. These patient-reported outcomes were assessed by means of validated instruments.
Conclusion
The authors conclude that community-based intervention targeting black barbershops involving the delivery of direct care including initiation and uptitration of blood pressure medications by pharmacist is safe and effective in reducing blood pressure in a population known to be at high risk for complications related to poorly controlled hypertension.
Limitations
Cluster randomization could not be blinded, leading to the possibility of ascertainment bias.
Blood pressure goal in the intervention group was lower (130/80) than what was likely used in the control group (presumed 140/80, per guidelines of the time).
Self-selection of motivated individuals may have led to overestimation of the effect size of the intervention.
The number of participants was higher in the control group than in the intervention group.
Short duration of follow up (6 months) limits ability to comment on long term findings, or whether the observed blood pressure reduction translates into improved clinical outcomes.
This study’s publication has generated blog posts, editorials, and commentary articles. John Mandrola is been impressed - and argues that this intervention will be cost effective if put into practice. A skeptical Anish Koka is not impressed, pointing to the 26 barbershops that couldn't recruit more than 1 patron, and that two-thirds of the identified individuals refused to participate despite significant inducements. A rogue opinion highlights the role of local knowledge - admittedly the crux of Victor and colleagues decision in moving the intervention to the barbershops. However, regardless of the views expressed, the one thing that can’t be challenged is the efficacy of the intervention in this study. As a nephrologist with an interest in public health, treating patients with multiple comorbidities, the study by Victor et al brought data or, as non scientist say, receipts. Hopefully, by addressing ways to implement and further research this intervention, the high rates of hypertension-related disability and death among black men with hypertension can be greatly reduced.